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Trial registered on ANZCTR

Registration number

ACTRN12619000223134

Ethics application status

Approved

Date submitted

9/02/2019

Date registered

14/02/2019

Date last updated

21/02/2019

Date data sharing statement initially provided

14/02/2019

Date results provided

14/02/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Feasibility of acupressure for post-operative nausea and vomiting

Scientific title

Feasibility of acupressure for post-operative nausea and vomiting: A pilot study utilising the FAME approach

Secondary ID [1]

N/A

Universal Trial Number (UTN)

N/A

Trial acronym

N/A

Linked study record

N/A

Health condition

Health condition(s) or problem(s) studied:

Post-operative nasuea

Postoperative vomiting

Post-operative pain

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Alternative and Complementary Medicine

Other alternative and complementary medicine

Anaesthesiology

Pain management

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A combined acupressure interventions consisting of Wristband and auricular acupressure
Wristband (Sea-Band Limited, Leicestershire, England). An elasticised fabric band with a protruding button applies pressure to Nei Guan PC6; an acupuncture point known to reduce nausea and vomiting. This is applied to both wrists prior to surgery and retained in place for 24 hours.
Auricular acupressure using seeds (Earseeds com Inc. NJ, 07666 USA). 4 ear seeds are taped to ear acupuncture points related to the reduction of nausea, vomiting, pain and anxiety on one ear, prior to surgery, and retained in place for 72 hours, with the patient applying manual pressure to the seeds 3 times daily. The points are Shen men, Point Zero, Lung and Subcortex. The choice of those points was based on published clinical trials.
All participants will receive the same standardised acupressure intervention in conjunction with usual anaesthetic and perisurgical care.
Compliance was monitored by the researchers who followed up with patients in person while patients were in the hospital and with phone calls after patients being discharged.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Treatment: Other

Comparator / control treatment

Standard postoperative nausea and vomiting (PONV ) management of a previous cohort of elective surgery patients from 12/05/2016 to 31/08/2016.

Control group

Historical

Outcomes

Primary outcome [1]

FAME framework is used Feasibility: What is the time commitment required to deliver acupressure within the peri-surgical environment This is assessed by the trial acupuncturists who recoded the time needed for the procesure

Timepoint [1]

During the preoperative period between admission and surgery, assessed by measuring the time taken to deliver acupressure to patients.

Primary outcome [2]

Appropriateness: Of those patients who had acupressure applied preoperatively, the percentage who used acupressure for 24 hours after surgery.

Timepoint [2]

24 hours after surgery, assessed by direct observation and questions to the patient.

Primary outcome [3]

Meaningfulness: Patient satisfaction with the use of acupressure, assessed by level of agreement with the statement "I am satisfied with the use of acupressure for my recovery" (Strongly agree / agree / neutral / disagree / strongly disagree).

Timepoint [3]

24 hours after surgery

Secondary outcome [1]

Effectiveness: Incidence of postoperative nausea and vomiting

Timepoint [1]

6, 24, 48 and 72 hours after surgery, Assessed by direct questioning of the patient.

Secondary outcome [2]

Requirement for rescue antiemetics

Timepoint [2]

6, 24, 48 and 72 hours after surgery, assessed by antiemetic medications recorded in the patient medication chart.

Secondary outcome [3]

Adverse events occurring during acupressure, including tightness, discomfort, pain, swelling and numbness.

Timepoint [3]

24 hours after the operation, direct questioning of the patient.,

Secondary outcome [4]

Quality of recovery: QoR-15 questionnaire

Timepoint [4]

24 hours after minor surgery or 72 hours after major surgery

Eligibility

Key inclusion criteria

1. Adults 18-90 undergoing elective surgery
2. PONV risk factor at 2 or over,
3. Able to give informed consent
4. For patients whose English is not sufficient for daily communication, interpreting service is required. Only those for whom we can locate an interpreter for the consent will be included.

Minimum age

18 Years

Maximum age

90 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. PC6 wrist area, or the auricle of the ear, not accessible for any reason including previous trauma, local infection or inflammation, or the need for medical/surgical access.
2. Active carpel tunnel syndrome
3. Participants who find the wristbands painful when wearing them, or if the wristbands constrict their circulation, will be excluded.
4. Participants who develop emergency surgical complications may be discontinued. Standard medical care will take precedence.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

N/A

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

N/A

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

This is a feasibility study. The primary outcome is not the clinical outcome, but the data related to the possibility of acupressure being used in the peri-operative setting.

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

The end points are feasibility and safety.
For feasibility, appropriateness, meaningfulness and safety: descriptive methods will be used.
For effectiveness: Chi square analysis is used to compare the incidence of PONV between the acupressure cohort with the historical cohort. T-tests are used to compare parametric data, including dose of anti-emetics, opioid medication, severity of pain and QR-15.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

10/10/2016

Date of last participant enrolment

Anticipated

Actual

5/04/2017

Date of last data collection

Anticipated

Actual

31/12/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Northern Hospital - Epping

Recruitment postcode(s) [1]

3076 - Epping

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

University

Name [2]

RMIT University

Address [2]

RMIT University, School of Health and Biomedical Sciences Address PO BOX 71, Bundoora, Vic 3083

Country [2]

Australia

Primary sponsor type

Hospital

Name

Northern Hospital

Address

: 185 Cooper St, Epping VIC 3076

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Sea-Band Limited, Leicestershire, England

Address [1]

Sea-Band Ltd, Lancaster Road, Hinckley, Leicestershire, LE10 0AW England

Country [1]

United Kingdom

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Health

Ethics committee address [1]

185 Cooper St, 
Epping VIC 3076

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/05/2016

Approval date [1]

08/09/2016

Ethics approval number [1]

HREC/15/NH/71

Ethics committee name [2]

Austin Health

Ethics committee address [2]

145 Studley Road 
PO BOX 55555
Heidelberg 
Vic 3084

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

06/12/2016

Approval date [2]

06/12/2016

Ethics approval number [2]

HREC/16/Austin/517

Summary

Brief summary

Post-operative nausea and vomiting (PONV) occurs in 30-50% of patients, and can prolong the hospital stay. Acupressure can safely and effectively reduce the incidence of PONV by up to 30%. Over 80% of surgical patients would be willing to try acupressure for PONV, however this intervention has not been incorporated into routine peri-operative care. This study is embedded in a large project that aims to systematically examine the barriers and enablers in the implementation of acupressure for PONV, and to develop and implement strategies for successful application of acupressure. 
The specific aim of this feasibility study was to identify the suitable form(s) of acupressure to be used in a peri-operative setting. We used FAME approach to study its feasibility, appropriateness, meaningfulness and effectiveness and safety. Our initial FAME analysis of the existing literature indicates moderate to strong support to the feasibility of per-operative acupressure for preventing and treating PONV. The two forms of acupressure identified from the literature were wristband and auricular acupressure. In this study, we trialled out these two forms of acupressure and to identify if, when and how acupressure could be implemented.
We hypothesised that this simple, non-drug intervention would be well-accepted by patients and staff, and with modification could be integrated into the per-operative setting without any difficulties. Acupressure could reduce PONV incidents and / or medication use. Data from the study also helped us identify barriers and enablers for later implementation. 
This study was conducted among patients undergoing elective surgery at Northern Hospital.

Trial website

N/A

Trial related presentations / publications

•	Layton, J; Briedis, J ; Stelmach, WS; Ma, J; Atme, J; Howat, P; Hau, R; Xue, CCL; Zheng, Z. (2016) Mechanisms underlying the effects of acupuncture on post-operative nausea and vomiting: a narrative review. Northern Health Research Week, July 206, Melbourne. 
•	Zheng, Z; Briedis, J; Stelmach, WS; Ma, J; Atme, J; Layton, J; Xue, C (2016) Implementing acupressure to improve post-operative nausea and vomiting- Protocol development. November 2016, The 5th  NHMRC Symposium on Research Translation. Melbourne 
•	Zheng, Z; Stelmach, WS; Briedis, J; Ma, J; Atme, J; Bourne, D; Crabbe, J; Fletcher, C; Reynolds, D; Howat, P; Hau, R; Layton, J;  Xue, CCL (2017) Health professionals’ attitudes towards incorporating acupuncture / acupressure into the management of post-operative nausea and vomiting: a hospital survey Northern Health Research Week, October 2017, Melbourne.
•	Zheng, Z; Stelmach, WS; Briedis, J; Ma, J; Atme, J; Bourne, D; Crabbe, J; Fletcher, C; Reynolds, D; Howat, P; Layton, J;  Xue, CCL;  Duong, J;  Maduri, M;  Nguyen, A;  Wijesinghe, P  (2017) Acupressure: preventative measure for post-operative nausea and vomiting. Northern Health Research Week, October 2017, Melbourne.
•	Zheng, Z. (2017) How to integrate acupuncture into routine management of post-operative nausea and vomiting? – a model based on  implementation science. Australasian Acupuncture & Chinese Medicine Annual Conference (AACMAC), May 2017, Brisbane .
•	Zheng, Z; Layton, J; Stelmach, W; Briedis, J; Ma, J; Atme, J; Bourne, D; Crabbe, J; Fletcher, C; Reynolds, D; Howat, P; Cleary, S; Xue, CCL  (2018) Implementing acupressure as an preventative measure for post-operative nausea and vomiting: preliminary results. Presented at 2018 ACORN & ASIORNA International Conference, May 2018, Adelaide.
•	Layton, J; Stelmach, WS; Crabbe, J; Briedis, J; Ma, J; Atme, J; Bourne, D; Cleary, S; Xue, CCL; Zheng, Z  (2018) Patterns of uptake of acupressure for reducing postoperative nausea and vomiting Northern Health Research Week, October 2018, Melbourne.
•	Zheng, Z; Layton, J; Stelmach, WS; Crabbe, J; Briedis, J; Ma, J; Atme, J; Bourne, D; Reynolds, D; Cleary, S; Xue, CCL (2018) Implementing a self-checklist to improve identification of the risk of post-operative nausea and vomiting among surgical patients. Northern Health Research Week, October 2018, Melbourne

Public notes

Contacts

Principal investigator

Name

Ms Wanda Stelmach

Address

Divisional Director, Surgery Northern Health 185 Cooper Street EPPING VIC 3076

Country

Australia

Phone

+61 3 8405 8814

Fax

+61 3 8405 8038

[email protected]

Contact person for public queries

Name

Zhen Zheng

Address

School of Health and Biomedical Sciences RMIT University PO BOX 71, Bundoora, Vic 3083, Australia

Country

Australia

Phone

+61 3 9925 7167

Fax

+61 39925 7178

[email protected]

Contact person for scientific queries

Name

Zhen Zheng

Address

School of Health and Biomedical Sciences RMIT University PO BOX 71, Bundoora, Vic 3083, Australia

Country

Australia

Phone

+61 3 9925 7167

Fax

+61 3 9925 7178

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• To researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor.

Conditions for requesting access:
• -

What individual participant data might be shared?

• De-identified data of the clinical outcomes: incidence of postoperative nausea and vomiting, postoperative pain, use of antiemetics and use of opioids and other surgical related outcomes: duration of the anaesthetise, category of surgery, length of hospital stay

What types of analyses could be done with individual participant data?

• IPD meta-analysis

When can requests for individual participant data be made (start and end dates)?

From:
Immediately following publication
ending 5 years following main results publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Access subject to approvals by Principal Investigator

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically